Technical Approvals and Certifications   

• American Food & Drug Administration (FDA) (Pre-market Notification 510(k), No K955470, Regulatory Class II)

• Certificate European (Medical Directive – Notified Body 0482)

• Department of Health (Licence to sell)

• BS EN 60601-1 : 1990 / BS 5724 : 1989 / IEC 601-1 : 1988
Medical Electrical Equipment
Part 1: General requirements for safety.

• EN 605601-1-2 : 1993
Medical Electrical Equipment
Part 1 : General requirements for safety
Part 2. Collateral standard: Electromagnetic Compatibility.

• MDS -201 – 0004
Electromagnetic compatibility standard for medical devices.

• CISPR Publication 11
Certificate of Compliance with the Radio Regulation (South Africa)
Radio Act (Act 3 of 1952)
Electromagnetic interference (South Africa)

• Electromagnetic interference (South Africa)
Awards

• Company of the year (1997)    Tech Pulse Manufacturing (Pty) Ltd

• At the Geneve Invention Show APS Therapy was awarded the gold medal in the medical division on the 1st of April 1998    APS Device

• Selected by Corporate Research Foundation as One of the Most Promising Companies in South Africa for the year 2000.    APS Technologies Limited

• Selected as one of the Top 300 Companies in South Africa in 2001.    APS Technologies Limited